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Alcon Research, LTD. has 28 FDA enforcement events on this register (40 product records) between 2012 and 2023: 27 device and 1 drug; the busiest year was 2016 with 8.
11% of its events are Class I; the most common class is Class II (25). 1 event is listed as ongoing; the recalling firm's address is in TX and PA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
Initiated Product (first record) Type Class Records Status 28 Jun 2023 Constellation Procedure Pak Device Class II 6 Ongoing 28 Aug 2018 CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use. Device Class I 4 Terminated 12 Jan 2018 Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System. Device Class II 2 Terminated 8 Aug 2017 Alcon Custom Pak Device Class II 1 Terminated 30 Jun 2017 ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery Device Class II 2 Terminated 25 May 2017 LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are… Device Class II 1 Terminated 27 Mar 2017 Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components Device Class II 1 Terminated 5 Sep 2016 Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal Device Class II 1 Terminated 28 Jul 2016 Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is… Device Class II 1 Terminated 28 Jul 2016 LAUREATE World Phaco System Device Class II 1 Terminated 24 May 2016 CENTURION Vision System Device Class II 1 Terminated 28 Apr 2016 CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks Device Class II 1 Terminated 14 Apr 2016 LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery. Device Class II 1 Terminated 1 Mar 2016 VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the… Device Class II 1 Terminated 9 Feb 2016 TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode 90016741106, UPC 3 00650 41636 8. Drug Class II 1 Terminated 29 Sep 2015 Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction. Device Class I 1 Terminated 21 Sep 2015 Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure. Device Class II 1 Terminated 11 Aug 2015 Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries. Device Class II 3 Terminated 11 Aug 2015 LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable suspension system for the microscope that… Device Class II 1 Terminated 2 Jun 2015 Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use… Device Class II 1 Terminated 28 Apr 2015 The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove. Device Class II 1 Terminated 15 Apr 2015 ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are… Device Class I 1 Terminated 11 Nov 2014 Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery. Device Class II 1 Terminated 30 Oct 2014 INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083, 8065741085, 8065741087, 8065741088, 8065741089, 8065741093, 8065741096, 8065741097, 8065741099, 8065750266, 8065750268, 8065750274, 8065750278, 8065750280, 8065750281,… Device Class II 1 Terminated 6 Oct 2014 INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts. Device Class II 1 Terminated 3 Jun 2014 eye-pak 7407 Tray Support Cover REF 8065740745 Device Class II 1 Terminated 16 May 2014 Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids… Device Class II 1 Terminated 29 May 2012 This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak,… Device Class II 1 Terminated
By type and class Class I: 11% of this firm's events; 18% of all events on the register.
Events by year Enforcement events for Alcon Research, LTD. by year initiated. Questions and answers How many FDA recalls has Alcon Research, LTD. had? 28 enforcement events (40 product records) on this register, 2012–2023: 27 device, 1 drug.
Are any Alcon Research, LTD. recalls ongoing? 1 event is listed as ongoing in the current openFDA export.
What class are Alcon Research, LTD. recalls? 25 Class II, 3 Class I. 11% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from? openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology .